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vTv Therapeutics said that the funds it saves through this process will allow it to focus on the Phase III development of TP399 and the company’s future growth.
The WHO’s latest decision is based on advice from an independent panel of experts who evaluated data from 16 randomized controlled studies.
In the staff documents, the FDA scientists expressed concerns over the Reata clinical data that was submitted.
The regulatory agency just placed new safety warnings on that drug class, which will impact AbbVie’s Rinvoq (upadacitinib), a drug the company has seen as a successor to its revenue-driving Humira.
The latest updates from Mesoblast Limited’s Phase III trial on rexlemestrocel-L show that the drug provides the highest benefit when used in patients with certain types of chronic heart failure.
The approval of Keytruda also now includes stage III melanoma following complete resection for pediatric patients 12 years and up.
The U.S. Food and Drug Administration is wrapping up 2021 with a fairly busy schedule for the month of December. Here’s a look at the first half of the month.
This afternoon, the U.S. Food and Drug Administration expanded the Emergency Use Authorization for Eli Lilly’s monoclonal antibody treatment combination of bamlanivimab and etesevimab.
The SEC announced charges against Usama Malik and his former live-in girlfriend Lauren S. Wood regarding an FDA decision during a trading black out.
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